Multi-functional medical device

ABSTRACT

An embodiment of a medical device includes a proximal handle, a distal end effector, an elongate member connecting the end effector to the handle, and a sheath enclosing at least a portion of the elongate member. The handle may include a first mechanism coupled to one of the sheath and the elongate member to move the sheath relative to the elongate member, a second mechanism coupled to the elongate member to rotate the elongate member relative to the handle, and a locking mechanism coupled to the first mechanism to hold the first mechanism in a default position. Embodiments also include methods of positioning the medical device to perform a medical procedure.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is based upon and claims the benefit of priority under35 U.S.C. §119(e) of U.S. Provisional Application No. 61/006,084 toTeague et al. filed on Dec. 18, 2007.

FIELD OF THE INVENTION

Embodiments of this invention relate to handle assemblies for medicaldevices for medical treatment, including, for example, immobilization,capture, repositioning, and fragmentation of objects within theanatomical lumens of the body. More particularly, embodiments of theinvention relate to improved medical handles for performing a number offunctions with a single hand of an operator.

BACKGROUND OF THE INVENTION

Medical devices having elongated body portions can be introduced througha body opening or tract and manipulated to move material (e.g., bloodclots, tissue, biological concretions, medical device components) withinthe body. Using such devices positioned at a treatment site through anelongated endoscope, laparoscope, or ureteroscope, an operator can viewand operate simultaneously at a remote surgical site. Lithotripsy andureteroscopy, for example, are used to treat urinary calculi (e.g.,kidney stones) in the ureter of a patient. In ureteroscopy, an operatorinserts a medical retrieval device such as a surgical grasper or a metalwire basket into the urinary tract to capture a stone in the retrievalassembly. Holding the stone in position within the retrieval assembly,the operator fragments it using a laser fiber. The operator can thenremove the fragments by the same or a different medical retrieval deviceor leave them in the body to be eliminated naturally.

Medical retrieval devices can include a sheath and an object-engagingunit, such as a basket, that is moveable relative to the sheath from acollapsed state within the sheath to another state in which the unitextends past the distal end of the sheath. The sheath typically extendsfrom a handle, located at the proximal end (i.e., the end away from thepatient) of the sheath to the object-engaging unit which is located atthe distal end of the sheath (i.e., the end near the patient and thatgoes into the patient). The handle includes a mechanism for actuatingthe object-engaging unit in order to move the object-engaging unitbetween collapsed and extended, expanded states.

During a urological procedure, a physician should be able to move thedistal end of the medical retrieval device in relation to the distal endof a ureteroscope. The physician may grip the sheath just proximal tothe point where the sheath is introduced into an auxiliary channelwithin the ureteroscope. As the physician operates the ureteroscope andpositions the sheath of the retrieval device, an assistant actuates thehandle at the physician's direction to retrieve or manipulate foreignmaterial.

In procedures that utilize a laser fiber and retrieval device, thephysician must carefully hold and position both items relative to eachother as well as relative to the ureteroscope. Actuation of the deviceswith the assistance of another operator can be overly time consuming,cumbersome, and lacking in tactile sensitivity. Currently, operators useat least two hands to manipulate urinary calculi and fragments thereof.To retain the object(s) or hold the retrieval device in a certainposition and location, the operator should maintain constant tension onthe handle. To rotate or move the device, the operator should maintainthat tension while rotating the handle, often requiring anotheroperator. There exists a need for a locking mechanism that allows aphysician to release tension on the handle without changing the tensionof the device on the captured object. Currently, physicians who need tomaintain a certain position of the basket in the process of manipulatinga stone must employ an attending assistant to actuate the device, whichadds cost and separates the physician from the tactile feel of thedevice.

Retrieval of fragments of urinary calculi within the body can beproblematic in that stones or stone fragments in the ureter oftenmigrate within the body before, during, and after a lithotripsyprocedure. Therefore, a need exists in the art for a retrieval devicethat facilitates the initial capture of material as well as maintainingits capture during further positioning and removal of the material anddevice. In addition, there exists a need in the art for a retrievaldevice that facilitates the controlled release of a stone or fragmentduring a surgical procedure. For example repositioning a target stonerelative to a lithotripter or releasing captured stones to large torelease without fragmentation requires controlled release of material.

Operators of medical retrieval devices need an improved handle thatallows for the introduction, positioning, and actuation of the devicewith a single hand. An improved handle would allow an operator tosimultaneously position and manipulate two devices relative to eachother. Additionally, using an improved handle, an operator couldsimultaneously manipulate an endoscope or an additional medical devicewithout assistance. Improved configurations for those devices shouldexhibit improved capabilities for sustained capture, controlled release,and limited patient tissue trauma while allowing operation of thedevices without the need for two hands or an assistant. There is also aneed for smaller handles that have more ability to manipulate objects sothat the primary operator has the highest possible tactile sensation ofand control over the object to be captured or manipulated.

SUMMARY OF THE INVENTION

Embodiments of this invention relate to handle assemblies for medicaldevices for medical treatment, including, for example, immobilization,capture, repositioning, and fragmentation of objects within theanatomical lumens of the body.

In one embodiment, the medical device includes a proximal handle, adistal end effector, an elongate member connecting the end effector tothe handle, and a sheath enclosing at least a portion of the elongatemember. The handle has a first mechanism coupled to one of the sheathand the elongate member to move the sheath relative to the elongatemember, and a second mechanism coupled to the elongate member to rotatethe elongate member relative to the handle.

In various embodiments, the device may include one or more of thefollowing additional features: wherein the first mechanism is arotatable piece that engages a longitudinally moveable piece fixedlyattached to one of the sheath and the elongate member; wherein therotatable piece is a first gear and the longitudinally moveable piece isa second gear; wherein a filled tooth of at least one of the first andsecond gears restricts the movement of the first mechanism; wherein therotatable piece is positioned for actuation by a thumb or finger of onehand of a user; wherein the second mechanism is positioned for actuationby a thumb or finger of the one hand, other than the thumb or finger foractuation of the rotatable piece; wherein the rotatable piece rotatesalong an axis perpendicular to a longitudinal axis of the device;wherein the second mechanism is a knob that rotates about a longitudinalaxis of the handle; wherein the second mechanism engages a mechanismthat fixedly retains the elongate member; wherein the knob is at leastpartially exposed on the handle; wherein the mechanism that fixedlyretains the elongate member is one of a pinch vise, a clip, a staple,and a clamp; further comprising a locking mechanism coupled to the firstmechanism to hold the first mechanism in a default position; furthercomprising a biasing member coupled to the first mechanism to hold thefirst mechanism in a default position.

Another embodiment of the invention is directed to a medical deviceincluding a proximal handle, a distal end effector, an elongate memberconnecting the end effector to the handle, and a sheath enclosing atleast a portion of the elongate member. The handle includes a firstmechanism coupled to one of the sheath and the elongate member to movethe sheath relative to the elongate member, and a locking mechanismcoupled to the first mechanism to hold the first mechanism in a defaultposition.

In various embodiments, the medical device may include one or more ofthe following additional features: wherein the locking mechanismcomprises a gear portion connected to the first mechanism that, in thedefault position, engages a lug of the handle; wherein the gear, in adepressed position, disengages from the lug and allows movement of thefirst mechanism; wherein teeth of the gear engage teeth of the lugwherein the locking mechanism comprises one or more springs biasing thefirst mechanism toward the default position, wherein the springscomprise two springs; wherein the first mechanism includes a rotatablepiece, and the one or more springs restrict rotation of the rotatablepiece

Another embodiment of the invention is directed to a method ofpositioning a medical device to perform a medical procedure includingproviding the medical device including a proximal handle, a distal endeffector, an elongate member connecting the end effector to the handle,and a sheath enclosing at least a portion of the elongate member; withthe distal end effector within the sheath, advancing the distal endeffector proximate to a treatment site within a body lumen of a patient;actuating a first mechanism of the handle with a thumb or finger of ahand of an operator to expose the end effector from the sheath; andactuating a second mechanism of the handle with a thumb or a finger ofthe hand of the operator to rotate the end effector about a longitudinalaxis of the device and relative to the handle.

In various embodiments, the method may include one or more of thefollowing additional features: wherein actuating the first mechanismcomprises turning a rotatable piece, the rotatable piece engaging alongitudinally moveable piece attached to one of the sheath and theelongate member; wherein the thumb or finger rotates the rotatable pieceabout an axis perpendicular to a longitudinal axis of the handle;wherein the hand of the operator actuates the first mechanism andthereafter actuates the second mechanism without the operatorrepositioning the hand on the handle; wherein actuating the secondmechanism comprises rotating a knob that is fixedly attached to theelongate member; wherein the thumb actuates the first mechanism and afinger actuates the second mechanism without the operator repositioningthe hand on the handle; wherein depressing the rotatable piece releasesthe first mechanism from a default position; wherein releasing therotatable piece places the first mechanism in a default position;wherein the end effector expand when exposed from the sheath; whereinactuating the second mechanism occurs after actuating the secondmechanism.

Another embodiment of the invention is directed to a method ofpositioning a medical device to perform a medical procedure, includingproviding the medical device including a proximal handle, a distal endeffector, an elongate member connecting the end effector to the handle,and a sheath enclosing at least a portion of the elongate member; withthe distal end effector within the sheath, advancing the distal endeffector proximate to a treatment site within a body lumen of a patient;actuating a first mechanism of the handle with a thumb or finger of ahand of an operator to expose the end effector from the sheath; andlocking the end effector in a longitudinal position relative to thesheath.

In various embodiments, the method may include one or more of thefollowing additional features: wherein actuating the first mechanismcomprises turning a rotatable piece, the rotatable piece engaging alongitudinally moveable piece attached to one of the sheath and theelongate member; wherein the thumb or finger rotates the rotatable pieceabout an axis perpendicular to a longitudinal axis of the handle;further including actuating a second mechanism of the handle with athumb or a finger of the hand of the operator to rotate the end effectorabout a longitudinal axis of the device and relative to the handle;wherein locking the end effector comprises releasing the first mechanismfrom actuation; further including unlocking the end effector from alongitudinal position relative to the sheath via actuation of the firstmechanism; wherein unlocking the end effector comprises depressing thefirst mechanism from a default position; wherein the first mechanism isdepressed against a biasing force.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate several embodiments of theinvention and together with the description, serve to explain theprinciples of the invention.

FIG. 1 illustrates a perspective view of a medical retrieval deviceaccording to an embodiment of the invention.

FIG. 2 is a view from the distal end of the embodiment of FIG. 1.

FIG. 3 is a top view of the embodiment of FIG. 1.

FIG. 4 is a detailed side cross-sectional view of the medical retrievaldevice of FIG. 1, along line A-A of FIG. 2.

FIG. 5 is a detailed view of the rack gear and telescoping cannula.

FIG. 6 is a cross-sectional view of the rotation knob connected to thepinch vise and mandril wire spindle along line T-T of FIG. 3 and lineU-U of FIG. 4, according to an embodiment of the invention.

FIG. 7 is a cross-sectional view, along line R-R of FIG. 3, showing anembodiment of the invention.

FIG. 8 is a side view of the embodiment of the invention show in FIG. 1.

FIG. 9 is a cross-sectional side view of a second embodiment of amedical retrieval device according to the invention.

FIG. 10A is a side view of a current handle in the art.

FIG. 10B is a view from the distal end of the handle of FIG. 10A.

DESCRIPTION OF THE EMBODIMENTS

Reference will now be made in detail to the exemplary embodiments of theinvention, examples of which are illustrated in the accompanyingdrawings. Wherever possible, the same reference numbers will be usedthroughout the drawings to refer to the same or like parts.

FIGS. 1-8 illustrate a first embodiment of a medical device according tothe invention. The medical device 10 includes a handle 12, a sheath 20,an elongate member 18, and an end effector 16. Sheath 20 may be flexibleand includes an internal lumen for receiving the elongate member 18 andthe end effector 16. As will be described more in detail below, the endeffector 16 and sheath 20 are moveable relative to each other in orderto achieve a first collapsed state of the end effector 16 (not shown) inwhich the end effector 16 is collapsed within the lumen of the distalend of the sheath 20 and a second state in which the end effector 16extends from the distal end of the sheath 20 and expands (shown in FIG.1).

The sheath 20 defines a lumen dimensioned to fully enclose the elongatemember 18 and the end effector 16 when the end effector 16 is in theretracted position (not shown). The sheath 20 extends from the distalend 24 of the handle 12 to the end effector 16. When extended past theproximal end of the end effector 16, the sheath 20 envelopes the endeffector 16, placing the end effector 16 in a collapsed state. When thesheath 20 moves proximally relative to the end effector 16, it exposesthe end effector 16 and leaves it in an expanded state (shown in FIG.1).

The sheath 20 may be formed from various biocompatible materials orcombination of biocompatible materials known in the art. Such materialsmay include, but are not limited to, polyamide, PEBAX, stainless steel(such as 300 and 400 series), cobalt, chromium, nickel, titanium,nitinol, thermoforming plastic, polytetrafluoroethylene (“PTFE”), andexpanded polytetrafluoroethylene (“ePTFE”). The sheath 20 may also be ametal coated with a polymer and may have one or more layers of material.Additionally, any of the materials discussed below or combinationthereof with respect to the elongate member 18 may form the sheath 20.

The length and diameter of the sheath 20 may vary depending on theapplication. A relatively long sheath 20 may be advantageous forretrieving stones or other calculi deep within the body of the patient.A sheath 20 having a relatively small diameter may be advantageous forretrieving stones from restricted passageways within the human urinarytract. The sheath 20 may be relatively flexible to facilitate theretrieval of stones or other material located in complex, tortuous bodystructures.

An elongate member 18 lies partially within the sheath 20. Elongatemember 18 is preferably a wire formed of a biocompatible material suchas stainless steel, cobalt, chromium, nickel, titanium, nitinol, orother suitable metal. The member 18 may be in the form of a flexibleshaft, coil, cable, or wire.

The elongate member 18 extends proximally from the end effector 16 intothe handle body 12. In one configuration, the proximal end of theelongate member 18 is connected to a movable internal portion of thehandle 12, such that movement of the internal portion will move the endeffector 16 relative to sheath 20 between expanded and collapsed states.In another configuration not shown, the proximal end of the sheath 20may connect to a movable internal portion of the handle body 12, suchthat movement of the movable internal portion will extend the sheath 20over the end effector 16 and thereby collapse the end effector 16.

The end effector 16 may comprise a basket, grasper, snare, claw, or anyother retrieval or grasping mechanism. The end effector 16 may alsocomprise any other mechanism for performing an operation in a body andmay be suitable for urological, endoscopic, or other like procedures.

FIG. 1 shows an embodiment having an end effector in the form of abasket having a plurality of moveable legs. The basket collapses into aclosed position when the elongate member 18 moves proximally relativeinto the sheath 20. When the basket moves distally relative to and outof the sheath 20, the basket expands to an open, unfurled, or spread outposition.

The proximal end of the elongate member 18 extends into the handle 12.Handle 12 and sheath 20 and elongate member 18 extend along the samelongitudinal axis L-L of the device, as shown in FIG. 1. Handle 12includes an elongated handle body, including a proximal handle end 22(farthest away from the patient) and a distal handle end 24. Endeffector 16 extends distally from elongate member 18 disposed within thelumen of the sheath 20. The elongate member 18 extends proximally fromthe end effector 16 into the handle 12. In this embodiment, the proximalend of the elongate member 18 is connected to an internal portion of theproximal end of the handle 12, but the elongate member 18 may extend toany part of the handle 12 between the distal end 24 and the proximal end22.

Handle 12 further includes a thumb wheel 28, configured to lie where thethumb is located when a hand grips the device 10, and a rotation knob32, configured to lie where a finger is located on the device 10. Handle12 is gripped in the palm of a hand. With a single hand, an operator cangrip the handle 12, turn the thumb wheel 28, and actuate the rotationknob 32. As shown in FIGS. 3 and 4, the thumb wheel 28 rotates about anaxis perpendicular to the longitudinal axis L-L of the handle 12; andthe rotation knob 32 rotates about an axis parallel to axis L-L.

A thumb or finger turns the thumb wheel 28 to extend and retract thesheath 20 along its longitudinal axis. The thumb wheel 28 is a disc orgear with teeth or ridges 29 along its circumference. Most of the thumbwheel 28 lies within the handle 12 between the middle and the distal end24 of the handle 12. Part of the wheel 28 is exposed to allow theoperator to grip the edge of wheel 28 with a thumb or finger to turn thewheel 28. The thumb wheel teeth 29 improve finger or thumb grip on thewheel 28 and engage the teeth 31 on a rack gear 30. Other textured orrough surfaces may line the circumference of thumb wheel 28 so that thewheel 28 can engage rack gear 30.

The thumb wheel 28 is held in a default position by a biasing system,such as one or more springs that hold the thumb wheel teeth 29 in placeso they will not engage the rack gear teeth 31 when the thumb wheel 28is in the default position. When the thumb wheel 28 is depressed, thebiasing system (not shown) yields and the thumb wheel teeth 29 engagethe rack gear teeth 31.

The handle 12 includes a locking mechanism to lock the thumb wheel 28 inplace when not depressed. As shown in FIG. 7, in this embodiment, thelocking mechanism includes a locking piece 36 and an inner gear 38.Inner gear 38 attached to the thumb wheel 28 within the handle 12 ispositioned under locking piece 36. The locking piece 36 attaches to oris otherwise an integral portion of the body of the handle 12. When thethumb wheel 28 is not depressed, teeth on the top of the outer edge ofthe inner gear 38 engage teeth or any textured surface on the inside ofthe locking piece 36 where it meets the inner gear 38 to hold the innergear 38 in place. In turn, the inner gear 38 holds the thumb gear 28 inplace and keeps it from rotating. When depressing or lowering the thumbwheel 28 toward the central axis L-L of the handle 12, thereby alsodepressing gear 38, the operator releases the teeth of the inner gear 38from the locking piece 36, enabling the thumb wheel 28 to turn and therack gear 30 and the sheath 20 to move along the L-L axis. By releasingthe thumb wheel 28 and permitting wheel 28 to raise to a defaultposition, the operator causes the teeth of the inner gear 38 to engagethe locking piece 36, which locks the thumb wheel 28 and the rack gear30 in place once again.

In this embodiment, the operator activates mechanisms on the handle tomove the sheath 20 toward the distal end of the device 10 relative toelongate member 18 by turning the top of the thumb wheel 28 toward theproximal end of the handle 22; or clockwise in FIG. 4. This will causethe end effector 16 to collapse into the sheath 20. By turning the topof the thumb wheel 28 toward the distal end of the handle 24, orcounter-clockwise in FIG. 4, the operator moves the rack gear 30 andsheath 20 toward the proximal end of the device 10, exposing the endeffector 16 for expansion.

The rack gear 30 includes a long element or rack that lies within thehandle 12. The long element of the rack gear 30 is connected to thesheath 20 and is configured to move along the longitudinal axis L-L ofthe handle 12. Teeth 29 on the edges of thumb wheel 28 engage orinterfit with teeth 31 on the long element of the rack gear 30, therebycausing movement of the rack gear when the thumb wheel 28 turns.

Engaging thumb wheel 28 telescopes a stiffening cannula 19 into rackgear 30 and sheath 20, providing the required support to push and pullgear 30 over the elongate member 18 without need for and additional,overlapping cannula. Telescoping cannula 34 prevents existing cannula 19from protruding into the proximal end of the sheath 20, common in priorhandles. The sheath 20 extends into at least the distal end of a lumenof rack gear 30 and fixedly connects to rack gear 30.

In other embodiments, the thumb wheel may utilize a toggle lock or anyother locking system to keep the wheel from moving inadvertently. Otherembodiments may also place the thumb wheel in a position for actuationby a finger instead of a thumb. The rack gear system may be configuredsuch that turning the thumb wheel toward the proximal end of the handlemoves the rack gear and sheath toward the proximal end of the handle.The system may also be configured to restrict the thumb wheel and rackgear to certain positions or favor certain positions over others byaltering the design of the surface of the thumb wheel or the surface ofthe rack gear.

Movement of the rack gear 30 along longitudinal axis L-L causes movementof sheath 20 along the same axis, in the same direction. The movement ofthe sheath 20 relative to the elongate member 18 along the L-L axis inthe direction of the end effector 16 eventually situates the endeffector 16 in its collapsed state, not shown here. Movement of thesheath 20 in the direction of the proximal end of the handle 12eventually situates the end effector 16 in its expanded or unfurledstate.

As shown in the FIGS. 1-4 and 6, this embodiment of the handle 12comprises a rotation knob 32 positioned between the proximal end 22 ofthe handle 12 and the thumb wheel 28. The rotation knob 32 lies withinthe handle 12 except for a part exposed through an opening in the handle12 through which the operator can actuate the knob 32. The opening islarge enough so that an operator of the device 10 may move the knob 32with a slight downward or upward motion of a finger (relative to theposition of the device shown in, for example, FIGS. 1 and 4). In anotherembodiment, the system may be configured so that the rotation knob isactuated by a forward or backward motion of a finger.

As shown in detail in the cross-sectional view of FIG. 6 (which is aview along axis U-U of FIG. 4), the knob 32 is shaped as a hollowcylinder whose longitudinal axis lies substantially along, or parallelto, the longitudinal axis L-L of the handle 12. Teeth or ridges surroundthe outer edges of knob 32, allowing a single finger to turn the knob32. The interior of knob 32 includes gear teeth. Those gear teethinterfit with the teeth lining the outer edge of a portion of a pinchvise 27, located at the proximal end 22 of the handle 12. The pinch vise27 grips stiffening cannula 19 and elongate member 18. When the operatorturns the rotation knob 32, the gear system rotates the pinch vise 27,and the torque of the pinch vise 27 turns the elongate member 18 aboutits longitudinal axis. When the elongate member 18 rotates about itslongitudinal axis, the end effector 16, attached to the distal end ofthe elongate member 18, also rotates about its longitudinal axis.

By turning the right edge of the rotation knob toward the bottom of thedevice, or clockwise in FIG. 6, the operator will rotate the endeffector 16 clockwise. By turning the right edge of the rotation knobtoward the top of the device, or counter-clockwise in FIG. 6, theoperator will rotate the end effector 16 counter-clockwise.

Other embodiments may place the rotation knob where it could be operatedby a thumb or another part of the hand instead of a finger.

Using the thumb wheel 28 and the rotation knob 32 on the handle 12 ofthis embodiment of the medical device 10, a physician can manipulate orposition the sheath 20 relative to the end effector with a single handby rolling the thumb wheel 28 with a thumb or finger, thereby moving thesheath 20 proximally or distally; and by actuating the rotation knob 32with a different finger, thereby rotating the elongate member 18 and theend effector 16 about their longitudinal axes.

Embodiments of invention enables medical devices whose handles arelighter and smaller than current handles in the art. FIGS. 8 and 2 showthe shapes and dimension of the embodiment of FIG. 1 relative to thoseof current handles in the art, shown in FIGS. 10A and 10B. As shown byFIG. 2 as compared to FIG. 10B, the handle in the embodiment of FIG. 1is slimmer than the cross-section of current handles in the art. Asshown by the side view of FIG. 8 as compared to FIG. 10A, the handle ofthe embodiment of FIG. 1 is shorter and thinner than current handles. Asa result, the handle in the embodiment of FIG. 1 weighs less thancurrent handles.

FIG. 9 illustrates another embodiment of a medical device according tothe invention. The FIG. 9 embodiment is similar in many respects to theembodiment shown in FIGS. 1-8.

The medical device 100 includes a handle 102, a sheath 118, an elongatemember 110, and an end effector 106. Sheath 118 may be flexible andincludes an internal lumen for receiving the distal end effector 106 atthe distal end of member 110. The end effector 106 and sheath 118 aremoveable relative to each other in order to achieve a first collapsedstate of the end effector 106 in which the end effector 106 is collapsedwithin the lumen of the distal end of the sheath 118 and a second statein which the end effector 106 extends from the distal end of the sheath118 and expands. The end effector 106 may comprise any of the mechanismsdescribed in the description of the end effector of the embodimentabove.

Handle 102 of medical device 100, sheath 118, and elongate member 110extend along the same longitudinal axis L-L. Handle 102 includes anelongated handle body, including a proximal handle end 130 and a distalhandle end 104. The end effector 106 extends distally from elongatemember 110 disposed within the lumen of the sheath 118. The elongatemember 110 extends proximally from the end effector 106 into the handle102 and may be in the form of a flexible shaft, coil, cable, or wire. Inthis embodiment, the proximal end of the elongate member 110 isconnected to the proximal end 130 of the handle 102.

Handle 102 further includes a thumb gear 114 with teeth 116, the exposedportion of the gear 114 positioned where the thumb lies when a handgrips the device 100. Handle 102 also includes a rotation knob 124,close to the proximal end of the handle and connected to a pinch vise126. In this embodiment, the rotation knob 124 is positioned much nearerthe proximal-most end of the handle 102, and closer to the outer edge ofthe hand gripping the handle, where the last two fingers may be bestpositioned to rotate the knob 124. The operator holds the handle 102 inthe palm of the hand; and with a single hand, the operator can grip thehandle 102, turn the thumb wheel 114, and actuate the rotation knob 124.As in the earlier embodiment, the thumb wheel 114 rotates about an axisperpendicular to the longitudinal axis of the handle 102; and therotation knob 124 rotates about an axis parallel to the longitudinalaxis of the handle 102.

In this embodiment, the thumb wheel 114 operates similarly to the thumbwheel in the embodiment above. Lever springs 112 hold the wheel 114 in adefault position such that the thumb wheel teeth 116 do not engage therack gear teeth 122 in the default position. One spring 112 exerts anupward force on a thumb wheel tooth 116, transferring torque in onedirection of the thumb wheel 114. Another spring exerts an upward forceon a tooth at another section of the thumb wheel 114, also transferringtorque in the opposite direction of the first spring 112. As a result,the force of the springs 112 lifts the thumb wheel 114 upwards from therack, but does not turn thumb wheel 114. This spring mechanism also actsas a locking mechanism, holding the thumb wheel in place when notdepressed.

As in the embodiment of FIGS. 1-8, when the top of the thumb wheel 114rotates toward the distal end 104 of the handle 102, thumb wheel teeth116 engage rack gear teeth 122 and the sheath 118, attached to rack gear120, moves toward the proximal end 130 of the device 100, exposing endeffector 106. When the top of the thumb wheel 114 rotates toward theproximal end 130 of the handle 102, the sheath 118 moves to the distalend of the device 100 to cover end effector 106. By releasing the thumbwheel 114, the operator disengages the thumb wheel 114 from the rackgear 120.

FIG. 9 shows the rack gear 120 telescoping a stiffening cannula 128 asthe thumb wheel teeth 116 engage the rack teeth 122. Rotating the thumbwheel 114 telescopes the stiffening cannula 128 into or out of the rackgear 120, providing the required support to push and pull the gear 120over the elongate member 110 without the need for an additional,overlapping cannula and without the existing cannula protruding into theproximal end of the sheath 118.

As shown in FIG. 9, one or more teeth 108 in the thumb wheel 114 may befilled, which can limit throw by preventing the rack gear 120 frommoving beyond a certain point when the filled tooth 108 meets the rackgear teeth 122. Filled teeth 108 can limit the distance that thumb wheel114 rotates, which limits the distance that the thumb wheel 114translates the rack gear 120, which in turn limits the distance that thesheath 118 can move relative to the elongate member 110. In thisembodiment, the movement of the rack gear 120 is restricted in that itcan not move past the point at which the filled tooth 108 engages therack gear teeth 122. Filled teeth can be positioned at various pointsalong the thumb wheel 108 or the rack gear 120 to limit throw.

The rack gear 120 attaches to sheath 118 inside the handle 102. Movementof the rack gear 120 along the longitudinal axis of the handle causesmovement of sheath 118 along the same axis, in the same direction.Movement of the sheath 118 in the direction of the proximal end 130 ofthe handle 102 eventually situates the end effector 106 in its openconfiguration. Movement of the sheath 118 in the opposite directiontoward the distal end eventually situates the end effector 106 in itscollapsed position within the sheath 118.

The rotation knob 124 lies near the proximal end of the handle 102. Inthis embodiment, the rotation knob 124 is external to the handle bodyand can be actuated by a thumb or fingers at any point around thecircumference of the handle 102. The rotation knob 124 is integrallyformed with a pinch vise 126, and rotating the knob 124 provides torqueto rotate the pinch vise 126, which rotates the stiffening cannula 128and elongate member 110. As the pinch vise 126 rotates with the knob124, it turns the end effector 106 about the longitudinal axis of thedevice in the same direction.

The configuration of medical devices 10 and 100 according to theinvention allows a single user to operate an endoscope with one hand andactuate the medical device with the other hand.

The operation of devices 10 and 100 is substantially the same and willbe described with reference to device 10 of FIGS. 1-8. To operate thedevice 10, an operator grasps the handle 12 in one hand and inserts thedistal end of the device 10 into a lumen of a patient's body while theend effector 16 is in a collapsed state within the sheath 20. Theoperator inserts the device further into the lumen until the endeffector 16 is in the proximity of the material within the lumendesignated for manipulation, capture, retrieval, movement, or otherdiagnostic or therapeutic procedure.

When appropriate, the operator depresses the thumb wheel 28 to engagethe rack gear; then, the operator turns the thumb wheel 28 on the handle12 with the thumb of the same hand that grips the handle 12. By turningthe top of the thumb wheel 28 toward the distal end of the device, theoperator moves the sheath proximally relative to the elongate member 18and the end effector 16, transitioning the end effector 16 to itsexpanded state. With the end effector in its expanded state, theoperator can capture, contact, or manipulate the material as needed.When the target material is in range, the operator can release the thumbwheel 28, locking the position of the wheel 28 and the sheath 20. Then,if needed, the operator turns the rotation knob 32, causing the elongatemember 18 and end effector 16 to rotate about the longitudinal axis L-Lof the device, thereby properly positioning the end effector 16 inrelation to the material. Turning knob 32 can be performed with a fingerof the same hand that is holding handle 12, without repositioning thathand after turning wheel 28. Then, by depressing and turning the top ofthe thumb wheel 28 toward the proximal end of the device, the operatormoves the sheath 20 distally in relation to the end effector 16, movingthe end effector towards its collapsed state. The operator therebygrabs, envelopes, snares, or captures the material and can furthermanipulate it by turning the thumb wheel 28 or the rotation knob 32.

Though shown with a retrieval device (and particularly a basket), thehandles described above can be used with any other medical devices whichrequire longitudinal positioning or rotation of medical devices at atreatment site. The reference to the use of a retrieval device is usedas an example and is not intended to limit the scope of the invention.

Other embodiments of the invention will be apparent to those skilled inthe art from consideration of the specification and practice of theinvention disclosed herein. It is intended that the specification andexamples be considered as exemplary only. The following embodiments areexemplary.

We claim:
 1. A medical device, comprising: a single handle having ahousing located at a proximal end of the device; a distal end effector;an elongate member connecting the end effector to the handle; a sheathenclosing at least a portion of the elongate member; the single handlecomprising: a first actuator coupled to one of the sheath and theelongate member to move the sheath relative to the elongate member,wherein the first actuator is moveable along an axis perpendicular to alongitudinal axis of the sheath, the first actuator including a firstrotatable member, a second rotatable member coupled to the firstrotatable member, and a linear translatable member, wherein the firstrotatable member extends radially outwardly of the second rotatablemember relative to the longitudinal axis of the sheath, and a secondactuator coupled to the elongate member to rotate the elongate memberand the end effector relative to the handle, and wherein, in a firststate, the second rotatable member is engaged with a portion of thehandle housing such that the first and second rotatable members areprevented from rotating, and in a second state, the second rotatablemember is disengaged from the portion of the handle housing and thefirst rotatable member engages the linear translatable member.
 2. Thedevice of claim 1, wherein the first rotatable member is a first gearand the linear translatable member is a second gear.
 3. The device ofclaim 1, wherein the first rotatable member is positioned for actuationby a thumb or finger of one hand of a user.
 4. The device of claim 3,wherein the second actuator is positioned for actuation by a thumb orfinger of the one hand, other than the thumb or finger for actuation ofthe first rotatable member.
 5. The device of claim 1, wherein the firstrotatable member rotates along an axis perpendicular to the longitudinalaxis of the sheath.
 6. The device of claim 1, wherein the secondactuator is a knob that rotates about the longitudinal axis of thesheath.
 7. The device of claim 6, wherein the knob is at least partiallyexposed on the handle.
 8. The device of claim 1, wherein the secondactuator engages one of a pinch vise, a clip, a staple, and a clamp thatfixedly retains the elongate member.
 9. A method of positioning amedical device to perform a medical procedure, comprising: with a distalend effector of a medical device positioned within a sheath of themedical device, advancing the distal end effector proximate to atreatment site within a body lumen of a patient, wherein the endeffector is connected to a handle of the medical device via an elongatemember positioned at least partially within the sheath; moving a firstactuator from a first state toward a second state by depressing a firstrotatable member of the first actuator along an axis perpendicular tothe longitudinal axis of the sheath, wherein in the first state, asecond rotatable member of the first actuator is engaged with a portionof a housing of the handle, and wherein in the second state, the secondrotatable member is disengaged from the portion of the handle housingand the first rotatable member engages a linear translatable member ofthe first actuator; extending the end effector distally of the sheath byrotating the first rotatable member and axially advancing the lineartranslatable member of the first actuator with a thumb or finger of ahand of an operator; and actuating a second actuator of the handle witha thumb or a finger of the hand of the operator to rotate the endeffector about a longitudinal axis of the sheath and relative to thehandle.
 10. The method of claim 9, wherein the thumb or finger rotatesthe first rotatable member about an axis perpendicular to thelongitudinal axis of the sheath.
 11. The method of claim 9, wherein thehand of the operator actuates the first actuator and thereafter actuatesthe second actuator without the operator repositioning the hand on thehandle.
 12. The method of claim 9, wherein the first state includes adefault position of the first actuator.
 13. The method of claim 9,further including releasing the first rotatable member to return thefirst actuator to the first state.
 14. The method of claim 9, whereinactuating the second actuator comprises rotating a knob that is fixedlyattached to the elongate member.
 15. The method of claim 9, furtherincluding expanding the end effector.
 16. The method of claim 9, whereinactuating the second actuator occurs after actuating the first actuator.17. A medical device, comprising: a handle having a housing located at aproximal end of the device; a distal end effector; an elongate memberconnecting the end effector to the handle; a sheath enclosing at least aportion of the elongate member; the handle comprising: a first actuatorcoupled to one of the sheath and the elongate member to move the sheathrelative to the elongate member, wherein the first actuator is moveablealong an axis perpendicular to a longitudinal axis of the sheath, thefirst actuator including a first rotatable gear, a second rotatable gearcoupled to the first rotatable gear, and a linear translatable gear,wherein the second rotatable gear is enclosed with the housing of thehandle, and a second actuator coupled to the elongate member to rotatethe elongate member and the end effector relative to the handle, andwherein, in a first state, the second rotatable gear is engaged with aportion of the handle housing such that the first and second rotatablegears are prevented from rotating, and in a second state, the secondrotatable gear is disengaged from the portion of the handle housing andthe first rotatable gear engages the linear translatable gear.
 18. Thedevice of claim 17, wherein the first rotatable gear is rotatable aboutan axis perpendicular to the longitudinal axis of the sheath.
 19. Thedevice of claim 17, wherein the second gear is a knob rotatable aboutthe longitudinal axis of the sheath.